Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori

Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02352701

Enrollment

320

Registered

2015-02-02

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2015-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Infections

Keywords

helicobacter pylori, ilaprazole, eradication, triple therapy

Brief summary

This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori

Detailed description

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori. Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

Interventions

DRUGNoltec tab. 10mg

Ilaprazole 10mg BID dosage form : delayed release tablet

DRUGChongkundang Amoxicillin Cap. 500mg

Amoxicillin 1000mg, BID dosage form : capsule

DRUGCravit Tab. 500mg

Levofloxacin 500mg, BID dosage form : film coated tablet

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. * Subject who fully understands conditions of clinical trial. * Subject who agrees to participate and spontaneously sign the ICF

Exclusion criteria

* Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin * Subjects who are taking contraindicated medications for experimental and concomitant drug. * Patients with abnormal levels in the laboratory tests * Total Bilirubin, Creatinine\> 1.5 times upper limit of normal * AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal * Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study. * Pregnant and/or lactating women * Reproductive aged women not using contraception * Uncontrolled diabetics * Uncontrolled hypertension * Uncontrolled liver dysfunction * Alcoholics * Subjects with a history of digestive malignancy within 5 years * Subjects with a history of gastrectomy or esophagectomy * Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption. * Subjects participating in a clinical trial before another trial wihin 30 days * Inconsistence judged subject by researcher

Design outcomes

Primary

Measure	Time frame	Description
The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy	Day 49±5	The eradication rate of H.pylori after 10 days treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test. The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days

Secondary

Measure	Time frame	Description
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events	Day 49±5	Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.
The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage.	Day 49±5	—
The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment.	Day 49±5	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026